Sr. Program Manager in Business Operations

• Oct 2022 - Present

Program Manager

• Aug 2021 - Oct 2022

● Lead Specialty Diagnostics projects from concept creation through product development and into release to operations & the commercial market; this includes creating documentation to define system requirements and specifications, managing scientists, engineers and external contractors through development, validation, documentation, and release of products via stage-gate process.● Work with a multi-disciplinary product development team and across business units to develop, evaluate, document, and introduce new products or enhancements for CMD’s digital transformation● Provide leadership and problem-solving for multi-faceted, cross-functional Product Management, Marketing, and Research & Development teams; Select and coordinate work of multi-site teams and/or contractors working on various project phases● Provide expertise in project planning and timeline development & management; develop a cost-effective plan and schedule for completion of project following a logical pattern for utilization of resources● Track and control progress, schedule, and associate costs to achieve completion of project within time and budget Show less

R&D Project Manager

• Apr 2021 - Aug 2021

● Lead projects from concept creation through product development and into release to operations & the commercial market; this includes creating documentation to define system requirements and specifications, managing scientists, engineers and external contractors through development, validation, documentation, and release of products via stage-gate process ● Work with a multi-disciplinary product development team and across business units to develop, evaluate, document, and introduce new products or enhancements for CMD’s digital transformation ● Provide leadership and problem-solving for multi-faceted, cross-functional Product Management, Marketing, and Research & Development teams; Select and coordinate work of multi-site teams and/or contractors working on various project phases ● Provide expertise in project planning and timeline development & management; develop a cost-effective plan and schedule for completion of project following a logical pattern for utilization of resources ● Track and control progress, schedule, and associate costs to achieve completion of project within time and budget Show less

Compliance Specialist

• Aug 2020 - Apr 2021

● Manages biologics GMP investigations, change control records, CAPA management, and improvement projects. ● Investigates biologics deviation events and customer complains utilizing root cause analysis techniques and leads team to evaluate pertinent aspects involved in determining deviation scope, impact, analysis, and CAPA. ● Analyzes and compiles data relative to defined KPI. ● Identifies areas for Continuous Process Improvement and applies operational excellence tools to ensures compliance with manufacturing processes in accordance with regulations. Show less

Sr. Operations Analyst (AbbVie)

• Jan 2017 - Aug 2020

● Project Manager in long term system upgrades which involved in budget planning, Gantt development, impact assessment, change plan establishment, and vendor communications. ● Project management in biologics manufacturing new equipment qualification to adhere to Data Integrity guidelines 21 CFR Parts 210-212● Process development work in fermenter SIP and CIP cycles such as commissioning draft and execution and validation support● Key operations member in knowledge transfer of upstream manufacturing techniques in between sister sites ● Support and assist in various regulatory agency audits (CDC, FDA, HPRA, and various foreign agencies)● Technical writer and reviewer for manufacturing procedures, risk assessments, and KPI analysis. ● Investigator, author, and reviewer in critical non-conformance event investigations Show less

Sr. Manufacturing Associate (Allergan)

• Sep 2015 - Jan 2017

● Production of select agent cultures with GMP standards and safety measures● Subject matter expert in biologics upstream production (bioreactor train and TFF harvester) ● Facilitator and assistant in change control management and deviation investigation● Biologics manufacturing equipment/systems life-cycle management ● Project manager in equipment/system upgrades and support in system qualification and validation

Lead Researcher (Graduate Program Publication)

• Aug 2018 - May 2020

● Collaborated with UCSF, conducted research in the field of breast cancer treatment and nano-particles with a focus on the production of NPs using 3D-printed Multi-inlet Vortex Mixers (MIVM). ● Collaborated with UCSF and Stanford, conducted research in the field of breast cancer treatment vs multiple doxorubicin nanoparticles with a focus on efficacy and stability via imaging analysis. ● Manuscript Pending (MDPI) – Assessing Prospects of Rapidly Generated Ultra-Large 3D Breast Cancer Spheroids: Studies with Chemotherapeutics and Nanoparticles. ● These researcher heavily utilized the use of following techniques: o Breast cancer cell manipulation with specialized robotic arms o MIVM / 3D structure engineering and fabrication o Stability Testing o Cytotoxicity Testing via live/dead assay and MTS assay Show less

Manufacturing Team Lead

• Jul 2014 - Aug 2015

● Special project assignment for knowledge transfer from/to Vienna, Austria (May – July 2015)● Subject matter expert in biologics upstream production (specialty in single-use bioreactor and culture harvest) ● Communication role in between the floor associates and management ● Production scheduling and material oversight● Facilitators for CAPA events, equipment commissioning, and non-conformance event investigation● Performance of documentation review and material issuance ● Proficient knowledge in cell culture production activities Show less

Manufacturing Associate II

• Sep 2013 - Jul 2014

● Constant improvement of production procedure documentation with the GDP/GMP guidelines● Proficient knowledge of Single Use Bioreactor production ● Team leader of the Safety team: lead safety investigations and conduct hazardous risk assessments● Training coordinator ● Work closely with Quality Assurance investigation and documentation of cGMP events.

Manufacturing Associate I

• Aug 2012 - Aug 2013

● Operation of pharmaceutical production complying with industrial GMP standard● Proficient knowledge of cell-line specific medium and buffers production ● Charterer & Team lead of the cycle count team that monitors and controls manufacturing expenditures ● Understanding and practicing of 5S● Work Closely with Quality Control in prevention of environmental control breaches

Financial Analyst Intern

• Mar 2011 - May 2011

Morgan Stanley Financial Training Program is an internship program provided by Morgan Stanley Sacramento. It brings students into the financial and stock market world. The goal of the program is to stimulate the minds of students and to provide the opportunity to comprehend real-time financial and stock market information through seminar, workshops, and research hours. Interns undergo a series of seminars that provide an overview of stock portfolio, retirement funds, and market analyzation techniques. The workshops and research hours provided the interns with opportunities in both sector and stock portfolio studies/presentations. Show less

Research Assistant

• Feb 2010 - May 2011

● Practices mutation technique and DNA/RNA/protein modification: observe and assist in the structural/functional studies of the ion channel. Specifically focusing on the CLC chloride channel and cyclic nucleotide-gated channels. ● Operation of Electrophysiology: voltage and current measurement of strain modifications utilizing frog eggs. ● Practices of molecular and recombinant DNA research techniques (Isolation, Cloning, Purification, Identification) ● Utilization of the operation of research lab wares/machines (Autoclave, Centrifuge, Titration Calculation, Aseptic Pippetting, Rockers) ● Practices the following laboratory research techniques: o Mutation technique - DNA/RNA/protein modification o Electrophysiology - Voltage and current measurement of strain modifications utilizing frog eggs. o Molecular/recombinant DNA research techniques - Isolation, Cloning, Purification, and Identification o Basic molecular/cell-biology laboratory tasks - SDS Page Gel Electrophoresis, PCR Amplification, Vital Staining, Protein Purification, and Buffer Calculation/Preparation o Small animal surgery - Frog dissection and suture Show less

Production Support Manager (Summer Contracts)

• Jun 2008 - Sep 2010

● Point of contact in between local and foreign crews ● Stage coordinator in Stage Production Support ● Translator The contracted role was for the following shows located in Taiwan: - Lady GAGA Asia Tour - May 2012 - Lady GAGA Taiwan Tour - October 2012 - Blue Man Group Show Tour - September 2009 - Phantom of the Opera Broadway Show Tour - August 2009 - Lion King Broadway Show Tour - June 2008 to September 2008 - International Insurance Society Conference - June 2008 Show less